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COMMONWEALTH OF PENNSYLVANIA

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Pennsylvania Code



Subchapter A. GENERAL PROVISIONS


GENERAL PROVISIONS

Sec.


284.1.    Scope.
284.2.    Permit-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements.
284.3.    Regulated medical or chemotherapeutic waste aggregation facilities.

GENERAL PROVISIONS


§ 284.1. Scope.

 This chapter sets forth application and operating requirements for a person or municipality that operates a regulated medical or chemotherapeutic waste facility. The requirements in this chapter are in addition to the applicable requirements in Chapters 271, 283 and 285 (relating to municipal waste management—general provisions; resource recovery and other processing facilities; and storage, collection and transportation of municipal waste).

Source

   The provisions of this §  284.1 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (317353).

§ 284.2. Permits-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements.

 (a)  The following processing facilities for regulated medical and chemotherapeutic waste will be deemed to have a municipal waste processing permit under this article if the following requirements in this subsection and subsection (c) are met:

   (1)  A processing facility with an autoclave if the following requirements are met:

     (i)   The facility processes at least 50% of its own regulated medical waste. The facility may not accept more than 50% of regulated medical waste for disinfection from small quantity generators that generate less than 220 pounds per month.

     (ii)   The facility does not process pathological waste or chemotherapeutic waste.

     (iii)   The facility may additionally process regulated medical waste to render the waste unrecognizable by processes such as thermal treatment, melting, encapsulation, shredding, grinding, tearing or breaking.

     (iv)   The processed waste is disposed of or processed in a landfill or incinerator authorized to accept the waste.

     (v)   The operator of the facility provides notice to the Department that includes the following:

       (A)   An intention to operate under permit-by-rule.

       (B)   The name and address of the facility.

       (C)   A description of the processing activity.

       (D)   The names and telephone numbers of the individuals responsible for operation of the processing facility.

   (2)  A processing facility with an incinerator if the following requirements are met:

     (i)   The facility processes at least 50% of its own regulated medical or chemotherapeutic waste. The facility may not accept more than 50% of regulated medical or chemotherapeutic waste for disinfection from small quantity generators that generate less than 220 pounds per month.

     (ii)   The facility may process other municipal waste generated onsite if the resulting ash is managed as processed regulated medical or chemotherapeutic waste.

     (iii)   The processed waste is disposed of or processed in a landfill or incinerator authorized to accept the waste.

     (iv)   The operator of the facility provides notice to the Department that includes the following:

       (A)   An intention to operate under permit-by-rule.

       (B)   The name and address of the facility.

       (C)   A description of the processing activity.

       (D)   The names and telephone numbers of the individuals responsible for operation of the processing facility.

   (3)  A processing facility with steam and superheated water disinfection if the following requirements are met:

     (i)   The facility processes at least 50% of its own regulated medical waste. The facility may not accept more than 50% of regulated medical waste for disinfection from small quantity generators that generate less than 220 pounds per month.

     (ii)   The facility does not process pathological waste or chemotherapeutic waste.

     (iii)   The facility may additionally process regulated medical waste to render the waste unrecognizable by processes such as thermal treatment, melting, encapsulation, shredding, grinding, tearing or breaking.

     (iv)   The processed waste is disposed of or processed in a landfill or incinerator authorized to accept the waste.

     (v)   The operator of the facility provides notice to the Department that includes the following:

       (A)   An intention to operate under permit-by-rule.

       (B)   The name and address of the facility.

       (C)   A description of the processing activity.

       (D)   The names and telephone numbers of the individuals responsible for operation of the processing facility.

   (4)  Onsite processing of liquid blood and body fluids using a glutaraldehyde-based or hypochlorite-based product that encapsulates or converts liquid blood or body fluids into solids or gels so that no free liquids remain. The Department may approve the use of other disinfectant-based products under these provisions if their efficacy can be demonstrated. The processed liquid blood and body fluids may be disposed of at a municipal waste landfill provided:

     (i)   No free liquids remain in the processed waste.

     (ii)   The landfill has received written approval from the Department authorizing disposal of the processed liquid blood and body fluids.

     (iii)   The facility does not process chemotherapeutic waste.

   (5)  Transfer facilities that temporarily store regulated medical or chemotherapeutic waste for less than 72 hours provided the stored waste remains in its original packaging, is not putrescent and does not attract vectors.

 (b)  Generators that process and disinfect less than 220 pounds per month of regulated medical waste onsite and render the waste unrecognizable will be deemed to have a municipal waste processing permit under this article if the requirements under subsection (c) are met. Generators that process and disinfect less than 220 pounds per month of regulated medical waste onsite without rendering the waste unrecognizable will be deemed to have a municipal waste processing permit under this article if the following requirements under this subsection and subsection (c) are met:

   (1)  The generator shall dispose of the processed waste in a landfill or have the waste incinerated in a facility that has written approval from the Department to accept this type of waste.

   (2)  The generator shall comply with the log and shipping paper requirements in §  284.701(b)(5) (relating to scope).

 (c)  The following requirements shall be met by facilities identified in subsections (a)(1)—(4) and (b) to operate under a permit-by-rule:

   (1)  The facility complies with Subchapters E and F (relating to segregation and storage; and collection and transportation) and Chapter 285 (relating to storage, collection and transportation of municipal waste).

   (2)  The facility has necessary permits under the environmental protection acts, and is operating in accordance with the environmental protection acts and the regulations promulgated thereunder, the terms and conditions of permits and orders of the Department.

   (3)  The operator maintains at the facility in a readily accessible place the following information:

     (i)   For a processing facility identified in subsection (a), a written plan for managing regulated medical waste generated at the facility, including waste handling, equipment operation and maintenance, processing method, disinfection monitoring procedures including quality assurance procedures, frequency of calibration and a description of how noninfectious waste is managed to prevent commingling.

     (ii)   For processing facilities subject to a permit-by-rule, daily records of the weight or volume of the waste that is processed, the method and location of disposal facilities for wastes from the processing facility, and waste handling problems and emergencies.

   (4)  Processing does not have an adverse effect on public health, safety, welfare or the environment.

   (5)  The waste is disinfected in accordance with §  284.321 (relating to regulated medical waste monitoring requirements).

   (6)  Disinfection occurs before or during processing of the waste.

   (7)  A log is maintained for each disinfection unit and is made available to the Department upon request. The log shall record the following:

     (i)   The date, time and operator for each use.

     (ii)   The dates and results of calibration.

     (iii)   The postdisinfection color reading of temperature sensitive tape and the results of biological indicator spore testing, in accordance with §  284.321 for steam disinfection facilities.

     (iv)   Results of ash testing which utilizes a methodology approved by the Department, for incineration facilities.

   (8)  Remaining waste is managed in accordance with the act and the regulations promulgated thereunder. For onsite autoclave facilities that do not render the waste unrecognizable, the treated or processed regulated medical waste shall be transported in accordance with Subchapter H (relating to tracking of regulated medical and chemotherapeutic waste).

   (9)  For incineration facilities, an air quality permit shall be obtained as required under the Air Pollution Control Act (35 P. S. § §  4001—4015).

 (d)  Chapter 271, Subchapter E (relating to civil penalties and enforcement) is applicable to facilities subject to permit-by-rule.

 (e)  Notwithstanding a provision in this section to the contrary, a facility will not be deemed to have a permit-by-rule if it causes or allows violations of the environmental protection acts, the regulations promulgated thereunder, the terms or conditions of a permit issued by the Department, or an order issued by the Department, or causes a public nuisance. A facility that is subject to permit-by-rule is not required to apply for a permit under this article, if that facility operates in accordance with this section.

 (f)  The requirements under Chapter 271, Subchapter D (relating to financial assurances requirements) that relate to bonding and insurance are waived for facilities that are deemed to have a permit under this section.

Source

   The provisions of this §  284.2 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (317354) and (273291) to (273303).

Cross References

   This section cited in 25 Pa. Code §  284.411 (relating to segregation).

§ 284.3. Regulated medical or chemotherapeutic waste aggregation facilities.

 (a)  Applicability. This section applies to operators of regulated medical or chemotherapeutic waste aggregation facilities.

 (b)  Permit-by-rule for regulated medical or chemotherapeutic waste aggregation facilities. The operator of an aggregation facility may operate under a permit-by-rule. For the operation of a regulated medical or chemotherapeutic waste aggregation facility to be authorized by a permit-by-rule, the owner or operator shall:

   (1)  Comply with the generator standards in Subchapter E (relating to segregation and storage).

   (2)  Only accept the following regulated medical or chemotherapeutic waste generated:

     (i)   Onsite or offsite by the operator of the aggregation facility.

     (ii)   By physicians in their independent practices or other medical personnel within the same building or complex of buildings.

 (c)  Noncompliance. The Department may require the operator of an aggregation facility operated under permit-by-rule to apply for and obtain a permit, or take other appropriate action, when the operator is not in compliance with the requirements for the permit-by-rule or is conducting an activity that harms or presents a threat of harm to the health, safety or welfare of the people or the environment.

Source

   The provisions of this §  284.3 adopted November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021.



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